FoundationOne Companion Diagnostic (F1CDx)
FDA device recall Z-1891-2025 · posted 2025-05-30 · Open, Classified
Recall details
- Recalling firm
- Foundation Medicine, Inc.
- Reason for recall
- An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
- Action taken
- On February 15, 2023, the physician was alerted of the amended report within the physician's portal. Physician was informed original report included an incorrect negative CDx claim on the claims page; the CDx variant information was displayed correctly in the tumor profiling section of the FDA-approved test report. It is requested that any impact to patient care be forwarded to Foundation Medicine.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- PQP
- Quantity affected
- 1 unit
- Distribution
- US Nationwide distribution in the state of WI.
- Date initiated
- 2023-02-15
- Date posted
- 2025-05-30
- Location
- Cambridge, MA
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